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BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis

NCT01499355 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2017-01-18

Study results available
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Summary

The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active, biopsy-proven lupus nephritis. The secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population.

Conditions

Interventions

BIOLOGICAL

BIIB023

BIOLOGICAL

Placebo

DRUG

mycophenolate mofetil

titrated to a target daily dose of 2 g (1 g twice daily)

DRUG

oral corticosteroids

oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Colombia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Malaysia
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Russia
  • South Korea
  • Spain
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01499355 on ClinicalTrials.gov